Drugs
Premier Pharmacy Labs has recalled several lots of morphine sulfate, hydromorphone HCl and neostigmine methylsulfate due to a potential lack of sterility assurance. An FDA recall notice says that microbial contamination was detected during routine testing of subsequent unreleased product lots “due to interaction between the product syringe and tamper
Drugs
Three Harvard Medical School researchers say that four years of experience with the FDA breakthrough therapy designation program indicate that while it has accelerated approval of some important drugs, the term “breakthrough designation” itself can be misleading to patients and healthcare providers. They suggest that Congress or FDA consider modifying
Drugs
FDA reportedly has opened a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine. Kaiser Health News reports that professor William Halford, who died 6/2017, injected subjects with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and
Drugs
FDA says that Haemonetics has received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose Plus and PL systems, with the drop in pH being accompanied by a yellow discoloration of the storage bag in some cases. The agency says
Drugs
A joint HHS/Justice Department Healthcare Fraud and Abuse Control Program won or negotiated over $2.4 billion in healthcare fraud judgments and settlements in FY 2017, according to a just-released report. In FY 2017, the report says, the Justice Department opened 967 new criminal healthcare fraud investigations. Federal
Drugs
FDA has approved a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Approval is based on data from the EXIST-3 Phase 3 study that
Drugs
Collegium Pharmaceutical is petitioning FDA not to approve any pending NDA for an extended-release (ER) oxycodone drug product, including Pain Therapeutics’ NDA for Remoxy ER, unless the product (1) bears abuse-deterrent labeling based on premarket studies conducted in each of the three categories in FDA’s 4/2015
Drugs
FDA has released the FDA-483 with 13 observations issued following a 3/19-3/27 inspection at Alkem Laboratories, a Daman and Diu, India, drug manufacturing plant. The observations were: * there is no quality control unit; * the quality control unit lacks the responsibility and authority to approve and reject
Drugs
FDA has told AbbVie that it requires three more months to review additional information about the results of liver function tests provided by the company as part of its NDA for elagolix in endometriosis-associated pain. The user fee review action target date has been extended to the third quarter.
Drugs
FDA has announced availability of four guidances issued by the International Council for Harmonization. They are: * Good Clinical Practice: Integrated Addendum – amends a previous guidance, Good Clinical Practice: Consolidated Guidance, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also
Drugs
A 2/14-3/20/17 inspection at Tris Pharma, Monmouth Junction, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/26 Warning Letter. Specific violations noted in the letter were * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
Patients for Access to Advanced Hemophilia Therapy is asking FDA to hold a public hearing to examine the effects on the nation’s medical system of “commerce-driven, court-ordered, drug access restrictions.” In its 4/8 petition, the group says it is concerned that Baxalta/Shire, as part of
Drugs
FDA has accepted for priority review a Verastem NDA for duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, indicated for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated review for treating relapsed or refractory follicular lymphoma.
Drugs
FDA has denied a 11/8/17 Insys Therapeutics petition asking that it decline to approve any ANDA for generic dronabinol oral solution that cites Syndros as the reference-listed drug if it relies on a waiver in lieu of establishing in vivo bioequivalence to Syndros and to require that
Drugs
FDA has published an International Conference on Harmonization addendum, Clinical Investigation of Medicinal Products in the Pediatric Population, to consider regulatory and scientific advances relevant to pediatric populations that have evolved since the 2000 publication of the original guidance. The addendum does not alter the scope of the original guidance
Drugs
FDA has released the FDA-483 issued following a 3/12-3/20 inspection at Alembic Pharmaceuticals Limited, Gujarat, India, an oral solid dosage drug manufacturer. Specific observations on the form were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Drugs
FDA has approved a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Previously, Exparel was approved for local administration to provide post-surgical analgesia. Interscalene brachial plexus nerve
Drugs
FDA has posted a draft guidance entitled: “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document provides recommendations about how and when to include pregnant women in drug development clinical trials. It also discusses the scientific and ethical issues that should be addressed when considering the
Drugs
FDA has released a draft guidance on “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document addresses relevant age groups to study and how early in a drug’s development that pediatric patients should be included for such drug products. The recommendations are based on input
Drugs
Unfavorable Phase 3 study results have caused Incyte and Merck to stop a Phase 3 study that was evaluating Incyte’s epacadostat in combination with Merck’s Keytruda in patients with unresectable or metastatic melanoma. The companies say that the ECHO-301/KEYNOTE-252 study did not meet the primary
Drugs
FDA commissioner Scott Gottlieb has told CNN that U.S. doctors should undergo mandatory training on pain management and the prescribing of opioid analgesics. He said that too many doctors continue to treat patients based on outdated training and said that training should occur when a doctor obtains a Drug
Drugs
FDA has issued complete response letters for two biosimilars — Truxima, a version of Roche’s Rituxan (rituximab), and Herzuma, a biosimilar of Roche’s Herceptin (tratsuzumab) — to be manufactured for Teva by Celltrion, a Korean pharmaceutical company. Celltrion said it was “committed to working with the regulatory agency to fully